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Quality Management System for Medical Devices

For achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success

The Purpose of a Quality Management System

A well-managed QMS is paramount to success.

qmsWrapper is a quality workflow process based system that not only fosters a team-based approach to compliance but introduces an innovative approach to managing QMS, called Managing Through Quality or MTQ - more effective and efficient way to manage your QMS.

The QMS Workflow Processes reduce:

 - Errors

 - Forgotten paperwork

 - Missed QMS reports

Your team should not guess what to do next; it should be defined for them, monitored and managed automatically.

MTQ helps to coordinate, control and direct your organization’s tasks and activities, to help you not only meet your customer’s quality requirements but also your regulatory and compliance requirements.

MTQ supports a team focused approach to QMS, ensures everyone works together towards desired quality outcomes and fosters a culture of team-based compliance. 

Everyone is involved!

"We invented qmsWrapper because we needed what you need: a system to help get your projects done in time, and stay FDA or ISO compliant."

In qmsWrapper, Quality Management is integrated with Project, Document and Risk management - in other words, QMS is sewn into the fabric of each module.

They exist both as separate modules so you can work within each as needs arise, but also they exist as highly integrated and interconnected to maximize productivity and provide a seamless team based compliance experience.



Benefits of qmsWrapper Quality Management System

qmsWrapper provides a step by step sequence of tasks with appropriate guides to help you correctly perform quality manager’s tasks.

  • MTQ (Manage Through Quality) - an innovation in management practices that use Project and QMS workflow processes to help quality managers achieve compliance.
  • QMS Processes driven Project Management and defined QMS Workflow Processes make ISO 13485 and FDA QSR compliance easier. (adaptable to ISO:9001)
  • Tagged as a QMS process or milestone, the tasks can be followed and backtracked to show what tasks were undertaken to resolve QMS related issues within the context of the Project itself. It creates a full circle of follow-up and coordination, fostering collaboration and continuous improvement.
  • Built-in Workflow Process Editor - gives you the freedom to build your own Workflow Processes.
  • Role-Based Security - ensures specified access to tasks, projects and associated content. Documents are controlled and stored according to their related projects.
  • Real-Time Visibility - real-time visual overview of all user tasks - percentage done, reports and assignments. Monitor who does what with what efficiency. Instantly identify any overlaps in the work and easily reassign tasks as needed, follow the over-all productivity and keep track of milestones, QMS issues, deadlines, upcoming events, to-dos and due dates at a glance. 

  • The electronic trail for data - A signed document, electronic or otherwise, now has a date stamped electronic trail, which is required and can be printed.
  • With the QMS Approval Workflows, automatic notifications are sent to the QMS Manager for approval. They are fully customizable! Create new approval workflow or attach an existing one to meet FDA 510k or ISO 13485 compliance.
  • Mirrored. Projects in the Project Management Module are mirrored in both, the Document Management Module and in the Quality Management module. This mirroring creates a simple way for the QMS Manager to follow, monitor and track all QMS events in and for any project. 
  • Built-in Team Messaging - Purpose-built and designed to support Team compliance. Chats and chat files are actually linked to particular projects or tasks - the simplest way to document any issue and save any Chat as a meeting to a particular project, complete with meeting minutes, agenda, scheduling, follow-up actions, add special ISO and FDA QSR attributions. Remain one step closer to full compliance.
  • Risk Management. The Project Management Module is directly connected to the Risk Management Module to ensure ISO and FDA compliance.

qmsWrapper fosters a team collaboration based approach to FDA 510k and ISO 13458 compliance - for better project productivity!  



Compliance Made Easy

Implementing a quality management system affects every aspect of your organization's performance. qmsWrapper is a holistic, flexible and scalable solution, created to address organization’s unique needs.

With overarching benefits and advantages like helping to communicate a readiness to produce consistent results, preventing mistakes, reducing costs, ensuring that processes are automated, defined and controlled, you are continually improving your organization.

Your QMS controls will have a direct impact on your design outputs, as well as your verification and/or validation activities.



qmsWrapper offers a full circle of QMS.



Get a Personal
Walkthrough to See:

  1. eQMS at its best, demoed to you as an auditor would see the audit.
  2. How to work your team to achieve product development success?